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Clinical study on Lianmei Rougui Recipe treatment for type 2 diabetes mellitus patients with the syndrome of heat in intestinal and cold in Gan

Clinical study on Lianmei Rougui Recipe treatment for type 2 diabetes mellitus patients with the syndrome of heat in intestinal and cold in Gan

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2023000031
Enrollment
Unknown
Registered
2023-08-22
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

Lianmei Rougui Recipe group:Lianmei Rougui Recipe

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus who were newly diagnosed within half a year and did not receive any hypoglycemic drug treatment ; the diagnostic criteria of Traditional Chinese Medicine syndromes of intestinal heat and liver cold syndrome ; aged between 18-65 years old ; fasting plasma glucose concentration < 11.1mmol / L, and glycated hemoglobin A1c< 9.5 % ; patients were informed and voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: In the past 1 month,patients had the acute metabolic disorders such as diabetic ketoacidosis or severe infection ; patients with severe primary diseases such as liver, kidney, hematopoietic system, malignant tumor or severe mental illness ; those who did not cooperate during the introduction period ( referring to those who could not cooperate with diet and exercise control and lifestyle adjustment ) ; pregnant or lactating women ; patients participated in other clinical trials in the past 3 months ; Patients with contraindications to metformin or unsuitable for metformin.

Design outcomes

Primary

MeasureTime frame
plasma glucose concentration 2 hours after meals;fasting plasma glucose concentration;glycated hemoglobin A1c;

Secondary

MeasureTime frame
low-density lipoprotein cholesterol;insulin resistance index;fasting fingertip blood glucose;fingerstick blood glucose 2 hours after meals;high-density lipoprotein cholesterol;total cholesterol;triglycerides;plasma insulin;

Countries

China

Contacts

Public ContactXiachengdong

Xiyuan Hospital of China Academy of Chinese Medical Sciences

xiachengdong72@163.com13693597579

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026